Document Control Specialist I

Job ID

12578

Type

Regular Full-Time

Company

Seattle Cancer Care Alliance

Location

US-WA-Seattle

Overview

The Seattle Cancer Care Alliance (SCCA), located in Seattle, Washington, is part of a dynamic collaboration among three organizations known nationally and internationally for their patient care and research: Fred Hutchinson Cancer Research Center, University of Washington, and Seattle Children's. Over the past 25 years, these institutions have worked together to support their mission of adult and pediatric oncology patient care services, research and education.

The Cellular Therapeutics Department (CTP) at SCCA is one of the largest cell therapy facilities in the United States and is on the cutting edge of new technologies for cancer therapy, including cell-based immunotherapy. We are committed to advancing treatment options for our patients through the translation of innovative research into clinical practice. We collaborate with our Alliance members (University of Washington, FHCRC and Seattle Children’s Hospital) as well as corporate entities.

CTP is responsible for apheresis, bone marrow harvest and all minimally manipulated therapeutic cell processing occurring at the SCCA for standard practice as well as clinical trials. Processing procedures range from cryopreservation and flow cytometric enumeration of cell proportions to more complex procedures such as cell selection, enrichment, and depletion. The laboratory is regulated by the FDA cGTP/cGMP standards, maintains College of American Pathologists (CAP) certification, and is accredited by the Joint Commission and the Foundation for the Accreditation of Cell Therapy (FACT).

The Quality Assurance Document Control Specialist is an integral member of the CTP team, collaborating across both the Apheresis Group (APH) and Cell Therapy Laboratory (CTL) as well as across organizations within and outside the Alliance. The primary responsibility of this position is to own and operate our department specific document control system. This is a hybrid electronic/manual system exclusive to the SCCA CTP. The position reports to the CTP Regulatory Compliance Manager. Regular interactions with medical, scientific and laboratory staff provide a stimulating and diverse environment.

We are seeking a highly motivated individual with initiative, excellent communication and collaboration skills, consummate professionalism and attention to detail. Previous experience with Document Control in medical, pharmaceutical or biotechnology industry is preferred. The qualified applicant should be dedicated to serving patients and SCCA’s vision to lead the world in translating scientific discovery into the prevention, diagnosis, treatment, and cure of cancer. The qualified applicant will be someone who is at ease working either independently or as part of a team.

Responsibilities

Own, operate and maintain SCCA Cellular Therapeutic's Document Control system

Performs technical writing and clerical/general departmental support for the preparation/edit of standard operating procedures (SOP) and other controlled documents.

Maintain understanding of applicable regulations, standards, terminology and practice at a level to be able to work effectively with CTP colleagues. This includes learning about new cell-based therapeutics entering clinical trials in which CTP participates.

Qualifications

Required:

High School Diploma or equivalent

At least three years of progressively complex administrative experience or equivalent

Strong skills with Microsoft Word, Excel, Outlook and Access

Excellent attention to detail

Outstanding organizational skills

Outstanding communication skills

Collaborative

Must be flexible, willing and able to work in team-based environment

Preferred:

BA/BS

One or more years of experience in the biotechnology or medical/pharmaceutical field

Experience with Adobe Pro

Our Commitment to Diversity

We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at escmail@fredhutch.org or by calling 206-667-4700.